FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
CerOX
K Number: K150268
·
Decision Nov 6, 2015
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
5
Review Days
275
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Basic Information
- Device Name
- CerOX
- K Number
- K150268
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Or-Nim Medical , Ltd.
- Date Received
- February 4, 2015
- Decision Date
- November 6, 2015
- Product Code
- DPW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
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